Hi it's not going to show in the database that it is approved due to it being approved before the actual laws took effect in 1932-1968. In 2006 there was a letter sent out to grandfathered companies that requested they get approval .

I have to make sure that it is not in a clinical stage of approval with any manufacture because new drug application (NDA) under review is considered confidential and can only be disclosed to the drug sponsor as per 21 CFR 312.130 and 21 CFR 314.430, respectively.

The only thing I can give you is straight from the FDA itself.Please be advised that the safety and efficacy claims for Sarapin have not been evaluated and approved by FDA.The FDA website, www.fda.gov, contains information regarding the drug approval process and the requirements for manufacturers of drug products.The “Marketed Unapproved Drugs Compliance Policy Guide explains FDA’s policies aimed at ensuring that all drugs marketed in the U.S., prescription and over-the-counter, have been shown to be safe and effective. This guidance can be found on FDA’s webpage at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf. Other related information can be found on http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htm, including resources for Heath Care Professionals to access to determine if a drug is FDA approved found at: Determining if a Drug is FDA Approved.If a company claims that its drug is grandfathered, it is that company’s burden to prove that assertion as stated in the regulations at 21 CFR 314.200(e) Contentions that a drug product is not subject to the new drug requirements.Being cleared it grandfathered in does not stipulate an approval